MAUDE Adverse Event Report: MEDLINE RENEWAL MICROAIRE; CARPAL TUNNEL RELEASE BLADE ASSEMBLY, (WHITE)

Catalog Number	81010R
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that through examination under a microscope, microscopic black specks were visualized in the post-carpal tunnel surgery wound.It was suspected that the microscopic black specks were from the reprocessed microaire's carpal tunnel release blade assembly.Per report, these microscopic black specks were successfully removed from the patient through an unidentified method.There was no report of prolonged anesthesia, a serious injury or another adverse patient event related to the reported incident.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample was not available to be returned for evaluation.Companion samples from the reported lot number were returned and the reported complaint is confirmed.A root cause could not be determined at this time.No additional information is available.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that microscopic black specks from the reprocessed microaire's carpal tunnel release blade assembly were noted in the wound post carpal tunnel surgery.

• Brand Name: MICROAIRE
• Common Device Name: CARPAL TUNNEL RELEASE BLADE ASSEMBLY, (WHITE)
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 8079169
• Report Number: 3032391-2018-00018
• Device Sequence Number: 13931600
• Product Code: NBH
• UDI-Device Identifier: 10888277375529
• UDI-Public: 10888277375529
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 81010R
• Device Lot Number: 375194
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention